Cleared Traditional

K131330 - GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT

K131330 is an FDA 510(k) clearance for GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ..., manufactured by Gold Standard Diagnostics. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K131330 · Gold Standard Diagnostics · Immunology device
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Optimized for regulatory review, auditing and printing
Jan 2014
Decision
265d
Days
Class 2
Risk

K131330 is an FDA 510(k) clearance for the GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on January 28, 2014 after a review of 265 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K131330

510(k) Number K131330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2013
Decision Date January 28, 2014
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 105d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 81
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K131330.
ImmuLisa Enhanced Centromere Antibody ELISA
K151559 · Immco Diagnostics, Inc. · Mar 2016
ELIA SCL-70S IMMUNOASSAY
K140493 · Phadia GmbH · Oct 2014
QUANTA FLASH CENTROMERE
K123880 · Inova Diagnostics, Inc. · Feb 2014
ANA SCREEN ELISA (IGG)
K131185 · Euroimmun US · Jul 2013
VARELISA RECOMBI ANA SCREEN, MODEL 12 596
K083188 · Phadia US, Inc. · Mar 2009
VARELISA RECOMBI CTD SCREEN, MODEL 13096
K050967 · Sweden Diagnostics (Germany) GmbH · Jun 2005